Actively Recruiting
Acute Immune Modulation by Probiotic Strain Bacillus coagulans JBI-YZ6.3 (BC4U) A Proof-of-Concept Study Comparing Three Doses to Placebo
Led by Natural Immune Systems Inc · Updated on 2024-12-31
24
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
Natural Immune Systems Inc
Lead Sponsor
J
Jeneil Biotech Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the immediate effects on the immune system of three different doses of a probiotic strain called Bacillus coagulans JBI-YZ6.3 (BC4U) compared to a placebo. This clinical proof-of-concept study involves 24 healthy adult participants aged 18 to 75 years. The focus is on understanding how the probiotic influences immune surveillance, immune cell activation, priming, and cytokine levels. Participants will take placebo and three escalating doses of the probiotic (0 mg, 100 mg, 200 mg, and 400 mg) in a cross-over design. Each treatment is given on separate clinic visits, spaced by a one-week washout period. Blood samples will be taken multiple times: 1 hour after arrival before dosing, and then 1, 2, and 3 hours after administration to assess the acute immune response. Throughout the study, participants will maintain consistent diet and lifestyle routines, including bland breakfasts and avoiding exercise, supplements, coffee, tea, and soft drinks around visit times. Researchers will measure immune communication and various immune panels during the three hours following dosing. Multiple blood draws will be performed, with safety and adherence closely monitored during the study period.
CONDITIONS
Official Title
Acute Immune Modulation by Probiotic Strain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults
- Age 18 to 75 years inclusive
- Veins easy to see in one or both arms to allow multiple blood draws
- Willing to maintain consistent diet and lifestyle throughout the study
- Willing to eat bland breakfasts on clinic visit days
- Willing to abstain from exercise and nutritional supplements on study visit mornings
- Willing to avoid coffee, tea, and soft drinks for at least one hour before clinic visits
- Willing to avoid music, candy, gum, and computer or cell phone use during clinic visits
You will not qualify if you...
- Previous major gastrointestinal surgery (minor surgery like appendix or gall bladder removal allowed)
- Taking daily anti-inflammatory medications
- Experiencing intense stressful events or life changes
- Engaged in intensive athletic training such as marathon running
- Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
- Having an unusual sleep routine (e.g., working graveyard shifts, irregular late nights)
- Unwilling to keep supplement intake constant during the study
- Anxiety about having blood drawn
- Pregnant, nursing, or trying to become pregnant
- Known food allergies to ingredients in the test product or placebo
AI-Screening
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Trial Site Locations
Total: 1 location
1
NIS Labs
Klamath Falls, Oregon, United States, 97601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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